Recall archive / FDA device enforcement
MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985... — FDA record Z-0647-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 9, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PACK, REF DYNJVB1280C; 7) D&C PACK, REF DYNJVB1280D
- Reason
- Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 478 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0647-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) REF CDS985431J, UDI/DI 10195327336110 (each) 40195327336111 (case), Lot Numbers: 23BBG608; 2) REF CDS985431K, UDI/DI 10195327451295 (each) 40195327451296 (case), Lot Numbers: 23JBF512, 23IBQ647; 3) REF CDS985431L, UDI/DI 10195327527273 (each) 40195327527274 (case), Lot Numbers: 24ABA205, 24ABW239, 24ABV349, 24CBR704, 24EBP485; 4) REF DYNJ44153G, UDI/DI 10195327412623 (each) 40195327412624 (case), Lot Numbers: 23KBB932; 5) REF DYNJ60924C, UDI/DI 10195327470333 (each) 40195327470334 (case), Lot Numbers: 23JBF913; 6) REF DYNJVB1280C, UDI/DI 10195327173951 (each) 40195327173952 (case), Lot Numbers: 23ELB178, 23CLA196, 23BLA668, 23BLA272; 7) REF DYNJVB1280D, UDI/DI 10195327482114 (each) 40195327482115 (case), Lot Numbers: 24CLA257, 23LLA915, 24CLA715, 24BLA712; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 11, 2024
- Recall initiation date
- Oct 9, 2024
- Center classification date
- Dec 5, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.